~ Buy the GATTEX KIT (teduglutide recombinant) Drug Profile, 2024 PDF Report in the Report Store ~

gattex kit Drug Patent Profile

Which patents cover Gattex Kit, and when can generic versions of Gattex Kit launch?

Gattex Kit is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in seven countries.

The generic ingredient in GATTEX KIT is teduglutide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide profile page.

DrugPatentWatch^® Generic Entry Outlook for Gattex Kit

Gattex Kit was eligible for patent challenges on December 21, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 16, 2026. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for gattex kit

International Patents:	8
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for gattex kit
DailyMed Link:	gattex kit at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for gattex kit

Constraining patent/regulatory exclusivity:

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT

NDA:

203441

Dosage:

POWDER;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for gattex kit

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 3
Allegheny Singer Research Institute	Phase 3
Takeda	Phase 2

See all gattex kit clinical trials

Pharmacology for gattex kit

Ingredient-type	Analogs/Derivatives Glucagon-Like Peptide 2
Drug Class	GLP-2 Analog
Mechanism of Action	Glucagon-like Peptide-2 (GLP-2) Agonists

Paragraph IV (Patent) Challenges for GATTEX KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GATTEX KIT	Injection	teduglutide	5 mg/vial	203441	1	2016-12-21

US Patents and Regulatory Information for gattex kit

gattex kit is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting gattex kit

FDA Regulatory Exclusivity protecting gattex kit

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes					Y
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes					Y
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes

International Patents for gattex kit

See the table below for patents covering gattex kit around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2334864
Japan	5019466
Japan	5001498
Spain	2427150
European Patent Office	1809318	TRAITEMENT DE PATIENTS ATTEINTS DU SYNDROME DE L'INTESTIN COURT AVEC COLON EN CONTINUITE (TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY)
Japan	2006342172	GLUCAGON-LIKE PEPTIDE-2 AND ITS THERAPEUTIC USE
Germany	60033437

Supplementary Protection Certificates for gattex kit

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0906338	92153	Luxembourg		PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338	433	Finland
0906338	CA 2013 00012	Denmark
0906338	2013/006	Ireland		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	1390009-7	Sweden		PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830
0906338	13C0013	France		PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338	C300578	Netherlands		PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830